Monthly Dosing of Atacicept in IgAN

NCT ID: NCT07020923

Last Updated: 2025-06-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Clinical Phase

PHASE2

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-05-29

Study Completion Date

2027-09-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

This is a Phase 2, open-label, multicenter, randomized study comprising parallel groups of participants receiving weekly and/or monthly doses of atacicept

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

This Phase 2 study is to explore the effectiveness, safety and tolerability of different dosing regimens of atacicept. Regimens include monthly and weekly dosing.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

IgA Nephropathy (IgAN) Berger Disease

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Atacicept Arm 1

Atacicept dose A administered subcutaneous (sc) injection monthly

Group Type EXPERIMENTAL

Atacicept

Intervention Type DRUG

Drug: Atacicept

Atacicept Arm 2

Atacicept dose B administered subcutaneous (sc) injection monthly

Group Type EXPERIMENTAL

No interventions assigned to this group

Atacicept Arm 3

Atacicept dose C administered subcutaneous (sc) injection monthly

Group Type EXPERIMENTAL

No interventions assigned to this group

Atacicept Arm 4

Atacicept dose D administered subcutaneous (sc) injection weekly

Group Type EXPERIMENTAL

No interventions assigned to this group

Atacicept Arm 5

Atacicept dose E administered subcutaneous (sc) injection weekly for 24 weeks, followed by monthly sc injections

Group Type EXPERIMENTAL

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Atacicept

Drug: Atacicept

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

VT-001

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Must have the ability to understand and sign a written informed consent form, which must be obtained prior to initiation of study assessments
* Adult male or female of ≥18 years of age, or as per country specific legally or nationally recognized adult age, who provides written informed consent prior to performing any study assessments
* Diagnosis of IgAN as demonstrated by renal biopsy conducted within 10 years
* Total urine protein excretion ≥0.75 g per 24-hour or urine protein-to-creatinine ratio (UPCR) ≥0.75 mg/mg based on a 24-hour urine sample
* eGFR ≥30 mL/min/1.73 m2 at screening, as per the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI)
* On a stable prescribed regimen of RASi (angiotensin converting enzyme inhibitor or angiotensin II receptor blocker) for at least 8 weeks that is at the maximum labeled or tolerated dose at screening and from screening to study Day 1

Exclusion Criteria

* IgAN secondary to another condition (eg, liver cirrhosis), or other causes of mesangial IgA deposition including IgA vasculitis (ie, Henoch-Schonlein purpura), systemic lupus erythematosus, dermatitis herpetiformis, ankylosing spondylitis
* Evidence of rapidly progressive glomerulonephritis (loss of ≥50% of eGFR within 3 months of screening)
* Evidence of nephrotic syndrome within 6 months of screening (serum albumin \<3.0 g/dL in association with UPCR \>3.5 mg/mg)
* Renal or other organ transplantation prior to or expected during the study, with the exception of corneal transplants
* Concomitant chronic renal disease in addition to IgAN (eg, diabetic nephropathy, primary focal segmental glomerulosclerosis, membranous nephropathy, C3 glomerulopathy, lupus nephritis)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Vera Therapeutics, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Zeeshan Khawaja

Role: STUDY_DIRECTOR

Vice President, Clinical Development

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Vera Therapeutics

Brisbane, California, United States

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

United States

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Vera Therapeutics, Inc. Clinical Trials Information

Role: CONTACT

(650)770-0077

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Brisbane, California

Role: primary

(650) 770-0077

Related Links

Access external resources that provide additional context or updates about the study.

http://www.veratx.com

Vera Therapeutics, Inc Company Website

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

VT-001-0020

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Mycophenolate Mofetil for IgA Nephropathy
NCT00863252 COMPLETED PHASE4